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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125019
Company: SPECTRUM PHARMS

Products on BLA 125019

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEVALIN	IBRITUMOMAB TIUXETAN	3.2MG/2ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125019

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2002	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ibriide021902L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125019_0000_ZevalinTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2018	SUPPL-227	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125019s227lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125019Orig1s227ltr.pdf
08/30/2013	SUPPL-213	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf
08/30/2013	SUPPL-210	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf
11/18/2011	SUPPL-194	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf
12/16/2010	SUPPL-185	Supplement		Label is not available on this site.
09/03/2009	SUPPL-156	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf
03/25/2008	SUPPL-135	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf
11/02/2007	SUPPL-132	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf
01/04/2007	SUPPL-117	Supplement		Label is not available on this site.
09/13/2005	SUPPL-92	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf
07/27/2005	SUPPL-88	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0088ltr.pdf
10/29/2004	SUPPL-70	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0070ltr.pdf
10/22/2004	SUPPL-58	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf
01/30/2003	SUPPL-8	Supplement		Label is not available on this site.

Labels for BLA 125019

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2018	SUPPL-227	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125019s227lbl.pdf
08/30/2013	SUPPL-213	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf
08/30/2013	SUPPL-210	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf
11/18/2011	SUPPL-194	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf
09/03/2009	SUPPL-156	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf
03/25/2008	SUPPL-135	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf
11/02/2007	SUPPL-132	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf
09/13/2005	SUPPL-92	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf
07/27/2005	SUPPL-88	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf
10/29/2004	SUPPL-70	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf
10/22/2004	SUPPL-58	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf
02/19/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf

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